Efficacy of Single Injection Femoral Nerve Block With Liposomal Bupivacaine for Total Knee Arthroplasty

Phase 4

Withdrawn

• Conditions: Total Knee Arthroplasty
• Interventions: Drug: Liposome Bupivacaine; Drug: Bupivacaine

• Registration Number: NCT01977339
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

Brief Summary

The purpose of this study is to compare the quality and duration of pain relief after a total knee replacement provided by a single shot of standard bupivacaine versus a single shot of liposomal bupivacaine, at the site of the femoral nerve. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Study Start: 2015-05
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female, ≥18 years of age
2. Scheduled to undergo primary unilateral TKA under general anesthesia.
3. American Society of Anesthesiology (ASA) Physical Status I-III
4. Able to demonstrate motor function by performing a 20-meter walk, and sensory function by exhibiting sensitivity to cold.
5. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria

1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
2. Planned concurrent surgical procedure (e.g., bilateral TKA).
3. Body weight < 50 kg (110 pounds) or a body mass index ≥ 40 kg/m2.
4. Contraindication to any of the pain-control agents planned for postsurgical use (i.e., morphine, hydromorphone, oxycodone, bupivacaine).
5. Previous participation in a liposome bupivacaine study.
6. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposome Bupivacaine	Liposome Bupivacaine	Single injection femoral nerve block of 10 cc of 266 mg liposome bupivacaine with 10 cc of normal saline
Bupivacaine	Bupivacaine	Single shot femoral nerve block with 20cc of 0.25% bupivacaine

Primary Outcome Measures

Name	Time	Method
Opiate consumption	72 hours	Compare the cumulative 72 hour opiate consumption after total knee arthroplasty (TKA)in patients who received a single dose of liposome bupivacaine with those who received a single shot femoral nerve block with 0.25% bupivacaine.

Secondary Outcome Measures

Name	Time	Method
Post-operative VAS scores	1 hr, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs	Patients will be asked to describe the pain intensity under two circumstances: pain at rest, and pain on movement. Postoperative pain intensity will be evaluated using the Visual Analogue Scale (VAS) system at 1, 4, 8, 12, 24, 48 and 72 hours. The VAS used will be the 11 point verbal response pain scale with 0 being no pain at all and 10 being the worst possible pain. The patients will be asked to rate their pain levels using this numeric scale.

Trial Locations

Locations (1)

St. Luke's-Roosevelt Hospital Center; 🇺🇸 New York, New York, United States